Research: one euro invested in a clinical study generates almost three
Among the lessons learned during the Covid-19 pandemic that should not be forgotten, there is certainly the awareness of the value of scientific research, the same that has allowed the development of vaccines in a very short time that have then allowed us to get to today with a peaceful coexistence with the virus. To remind us of the benefits that research brings to everyone are the specialists of the Federation of Oncologists, Cardiologists and Hematologists (Foce) meeting in Rome for the national conference dedicated to the 'Value of clinical research in oncology, hematology and cardiology'. Data in hand, the specialists let it be known that one euro invested in a clinical study generates almost 3 (2.95) in terms of benefits for the National Health Service.
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The leverage effect of cancer research
The leverage effect, determined by the costs avoided for the free provision of experimental therapies and diagnostic services to people enrolled in the trials, reaches as much as 3.35 euros in cancer trials. Suffice it to say that the average cost of oncology research is 512,000 euros, but those avoided are more than double, equal to 1,200,000 euros. A potential saving of approximately 400 million euro each year has been estimated, in the area of oncohematology alone. Figures that reach macroeconomic dimensions, of a few billion euros, if we consider all the experiments carried out in Italy. Overall public and private investments in this sector, in Italy, amount to over 750 million euros a year, of which 92% from pharmaceutical companies for profit studies. Furthermore, approximately 80% of the research carried out in the Peninsula is of international origin and represents an export of services, contributing positively to the trade balance of our country. In particular, oncology absorbs as much as 40% of trials (330 in 2021).
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More research funds
Unfortunately, however, our country is still far from the objective of investing 3% of GDP in research, as recommended by the European Union, stopping at 1.43%, with only 0.5% of public investment. “Scientific research is the key to guaranteeing every person the best opportunities for treatment and health care – says Minister Schillaci. The Decrees on Ethics Committees, which I recently signed and which constitute a decisive step forward towards the full implementation in our legal system of the European Regulation 536 of 2014 on clinical trials, fit into this broad-based vision. research and healthcare in general have always been lower than the European average. The time has come to reverse course."
The benefits of research for patients
Despite the few investments, in five years the number of new clinical trials authorized in our country has increased exponentially: from 564 in 2017 to 818 in 2021, in five years there were 340. Every year in Italy about 40 thousand citizens are involved in the experiments. Two-thirds of the trials involve neoplasms, haematological and cardiovascular diseases, which among other things produce two-thirds of the annual mortality. “The advantages deriving from research - he explains Francesco Cognetti, president Foce - they are 360 degrees. Patients can benefit from innovative therapies well in advance of their availability, resulting in improvements in survival and quality of life".
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The benefits for the entire health system
But the benefits of research extend far beyond that. “Healthcare companies that host experimental centers - continues Cognetti - enjoy an increase in health care and professional growth of the personnel involved. Furthermore, the development of new drugs is followed by a strong social utility, for the lengthening of the average life of citizens. Clinical research is, therefore, an engine of economic and social development for the country". He also points it out Guido Rasi, Past Executive Director of the European Medicines Agency (EMA) and Full Professor of Microbiology at the University of Tor Vergata in Rome: "The clinical research sector is an excellence of the scientific and economic system in Italy and, for decades, it is an engine of advancement for the whole country. Unfortunately, this role is not always perceived in the vastness of its scope by all the actors involved and unexpressed potential remains. Times and costs for starting clinical studies compatible with international competition must be guaranteed, capitalizing on the experience gained during the Covid-19 pandemic, and promoting collaboration between the public and private sectors".
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Oncological research
And within the various lines of clinical research, oncology is a turbocharged engine. In 2022, 390,700 new cases of cancer were estimated in Italy. 65% of women and 59% of men are alive 5 years after diagnosis, a very important result achieved also thanks to innovation. “Half a century ago we knew nothing of the molecular basis of tumors – he explains Charles Cross, professor of Internal Medicine at Ohio State University (USA). “We then discovered that neoplasms are caused by somatic genetic alterations, which occur during our lifetime. The identification of these mutations has allowed the development of targeted drugs, molecularly targeted therapies. And the latest frontier of immuno-oncology, in some cases, makes it possible to chronicle very aggressive diseases such as metastatic melanoma. Today, about a billion dollars is needed to develop an innovative anticancer drug. If pharmaceutical companies fail to recoup these costs, they will stop investing in research. The challenge is to identify the difficult compromise between the drive for innovation, which supports the development of new molecules, and the sustainability needs of healthcare systems. A pact between industry, clinicians, institutions and universities is the way forward to give new impetus to research".
Research progress in the pediatric field
The excellence of oncological research also concerns the pediatric area. "Today we are able to definitively heal about 80% of children who get cancer in childhood, with cure rates for some neoplasms that even reach over 90%", he explains Frank Locatelli, president of the Superior Council of Health. “Investments in research and international scientific collaborations have made it possible to achieve these important goals. On the one hand, targeted therapies and immuno-oncology on the other have changed the scenario. The next challenge is to use Car T cell therapy, based on the patient's genetically modified lymphocytes, which has already been shown to be effective in hematologic cancers, even in solid malignancies."
Research in hematology
There have also been many advances in the hematological field and in fact today about 75% of adult patients affected by hematological tumors are cured or have a long survival with a good quality of life. “Our country - he says Paul Corradini, president of Sie (Italian Society of Hematology) - has contributed significantly to the development of many innovative therapies in hematological cancers. Among the most promising therapies are the Car-T cells which are reimbursed in our country in the most aggressive lymphomas, in acute lymphoblastic leukemia and soon in multiple myeloma, in patients already undergoing various lines of therapy. The advantages of clinical trials are not only for the patients, in fact the National Health Service obtains a benefit thanks to the avoided costs for therapies, supported by the sponsor companies of the trials. This saving is not obvious, because it is not tracked in the hospital accounts, but it is very significant".
The role of pharmaceutical companies
Foce's specialists wanted to underline the positive role of pharmaceutical companies in the development and implementation of research. “The investment of the sponsor company, in addition to the experimental and control drug - Corradini reiterated - often includes other services necessary for data collection or patient selection, such as diagnostic tests, centralized laboratory analyzes and genetic tests. These performances generate direct investments and, potentially, avoided costs for the system. Furthermore, they often determine an additional benefit for the patient, who can take advantage of more frequent and accurate diagnostic services or access genetic tests capable of modifying the treatment path". It also intervenes on this point Pasquale Perrone Filardi, president of Sic (Italian Society of Cardiology): “The role of drug companies is driving the overall financing of trials. In fact, public support in this sector has always been undersized in Italy. In recent years, the awareness of the value of clinical research on the part of institutions and citizens has increased. But more public resources are needed. In this way, Italy will be able to increase its competitiveness and attractiveness as an optimal location for carrying out trials”.
The digitization of research
The Foce Conference also discussed the digitization of Italian research centres, which are considered excellent for their undisputed scientific and academic quality. "We need to improve the organization of the experimental centers of our country" - he underlines George Palu, president of Aifa (Italian Medicines Agency) - standardizing processes and procedures. It is also necessary to adapt its technical and instrumental equipment, especially digital, and increase its workforce. One of the major critical issues concerns the trial start-up times, characterized by a long and difficult regulatory process. These elements can undermine the attractiveness of Italy. We hope that the new standards established by the European Regulation 536 of 2014, which harmonized the evaluation and authorization process of a clinical study conducted in several Member States, will make it possible to overcome these difficulties, speeding up decisions and reducing bureaucratic constraints".
European regulations
Italy has finally complied with EU legislation, thanks to the four decrees signed by the Minister of Health on 30 January 2023. "Our country risked losing the new clinical research train that had already left on 31 January 2022, with the 'entry into force of the 'Clinical Trial Information System' (CTIS), the single continental portal for trials, established by the European Regulation”, continues Cognetti. Italy remained stationary in a one-year transition phase and, thanks to Minister Schillaci's decision, we managed to join the rest of the continent. Today our country is in fourth position in Europe for clinical studies adhering to the new European Regulation, after France, Spain and Germany. Lost time must be made up for."
